Trial Outcomes & Findings for A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) (NCT NCT00382993)

NCT ID: NCT00382993

Last Updated: 2017-02-02

Results Overview

Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 169 participants
• Primary outcome timeframe: 2 - 24 Hours Post-Dose
• Results posted on: 2017-02-02

Participant Flow

Participant milestones

Measure	Placebo/Sumatriptan-Naproxen Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).	Sumatriptan-Naproxen/Placebo Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
Migraine Attack 1 (Period 1) STARTED	84	85
Migraine Attack 1 (Period 1) COMPLETED	70	67
Migraine Attack 1 (Period 1) NOT COMPLETED	14	18
Migraine Attack 2 (Period 2) STARTED	70	67
Migraine Attack 2 (Period 2) COMPLETED	68	63
Migraine Attack 2 (Period 2) NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Placebo/Sumatriptan-Naproxen Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).	Sumatriptan-Naproxen/Placebo Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
Migraine Attack 1 (Period 1) Lost to Follow-up	7	2
Migraine Attack 1 (Period 1) Withdrawal by Subject	1	3
Migraine Attack 1 (Period 1) Lack of opportunity to treat migraine	0	5
Migraine Attack 1 (Period 1) Did not meet Eligibility Criteria	3	3
Migraine Attack 1 (Period 1) Other (no additional data present)	3	5
Migraine Attack 2 (Period 2) Lost to Follow-up	1	0
Migraine Attack 2 (Period 2) Lack of opportunity to treat migraine	0	1
Migraine Attack 2 (Period 2) Did not meet Eligibility Criteria	0	1
Migraine Attack 2 (Period 2) Protocol Violation	0	1
Migraine Attack 2 (Period 2) Other (no additional data present)	1	1

Baseline Characteristics

A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2)

Baseline characteristics by cohort

Measure	Safety Population n=139 Participants Safety Population - Participants who were randomized and who treated at least 1 migraine attack with investigational product.
Age, Continuous	40.1 years STANDARD_DEVIATION 11.11 • n=93 Participants
Gender Female	129 Participants n=93 Participants
Gender Male	10 Participants n=93 Participants
Race/Ethnicity, Customized White/Caucasian/European American	123 participants n=93 Participants
Race/Ethnicity, Customized African American	10 participants n=93 Participants
Race/Ethnicity, Customized Other	6 participants n=93 Participants

PRIMARY outcome

Timeframe: 2 - 24 Hours Post-Dose

Population: ITT (Intent-to-Treat) Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose	10 Participants	41 Participants

SECONDARY outcome

Timeframe: 2 Hours Post-Dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine Headache Pain Free at 2 Hours Post-Dose	19 Participants	59 Participants

SECONDARY outcome

Timeframe: 0-24 Hours Post-Dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label).

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Rescue Medication Use During 0 - 24 Hours Post-Dose	72 Participants	29 Participants

SECONDARY outcome

Timeframe: 0.5, 1, 4, and 8 Hours Post-Dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose Pain Free at 0.5 Hour Post-Dose	3 Participants	3 Participants
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose Pain Free at 1 Hour Post-Dose	12 Participants	33 Participants
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose Pain Free at 4 Hours Post-Dose	23 Participants	83 Participants
Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose Pain Free at 8 Hours Post-Dose	32 Participants	88 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine	8 Participants	34 Participants

SECONDARY outcome

Timeframe: 2, 4 , and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose Migraine-Free at 2 Hours Post-Dose	15 Participants	46 Participants
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose Migraine-Free at 4 Hours Post-Dose	20 Participants	76 Participants
Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose Migraine-Free at 8 Hours Post-Dose	30 Participants	83 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine-Associated Sinus Pain	44 Participants	75 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of participants who had sinus pain at the time of assessment.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Sinus Pain at Baseline	47 Participants	56 Participants
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Sinus Pain at 2 Hours Post-Dose	40 Participants	41 Participants
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Sinus Pain at 4 Hours Post-Dose	36 Participants	27 Participants
Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Sinus Pain at 8 Hours Post-Dose	27 Participants	20 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine-Associated Neck Pain	29 Participants	65 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of Participants with neck pain at the time of assessment.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Neck Pain at Baseline	81 Participants	75 Participants
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Neck Pain at 2 Hours Post-Dose	71 Participants	52 Participants
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Neck Pain at 4 Hours Post-Dose	65 Participants	38 Participants
Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine-Assoc Neck Pain at 8 Hours Post-Dose	51 Participants	29 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine-Associated Photophobia	23 Participants	65 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of participants who had photophobia (sensitivity to light) at the time of assessment.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Photophobia-Baseline	100 Participants	101 Participants
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Photophobia 2 Hours Post-Dose	84 Participants	48 Participants
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Photophobia 4 Hours Post-Dose	69 Participants	31 Participants
Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Photophobia 8 Hours Post-Dose	51 Participants	25 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine-Associated Phonophobia	30 Participants	68 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of participants who had phonophobia (sensitivity to noise) at the time of assessment.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Phonophobia-Baseline	75 Participants	80 Participants
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Phonophobia 2 Hours Post-Dose	68 Participants	42 Participants
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Phonophobia 4 Hours Post-Dose	56 Participants	27 Participants
Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Assoc Phonophobia 8 Hours Post-Dose	42 Participants	20 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Freedom From Migraine-Associated Nausea	38 Participants	79 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Associated Nausea at Baseline	40 Participants	48 Participants
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Associated Nausea 2 Hours Post-Dose	43 Participants	33 Participants
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Associated Nausea 4 Hours Post-Dose	35 Participants	18 Participants
Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose Migraine Associated Nausea 8 Hours Post-Dose	27 Participants	14 Participants

SECONDARY outcome

Timeframe: 2 - 24 hours post-dose

Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Sustained Complete Pain/Symptom-Free	7 Participants	30 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 4, and 8 hours post-dose

Population: ITT Population - included subjects in the Safety Population who provided an evaluation of their study drug for at least one treated attack.

Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. "Complete pain/symptom-free" was defined as migraine-free, neck pain-free, and sinus pain free.

Outcome measures

Measure	Placebo n=132 Participants	Sumatriptan/Naproxen Sodium n=134 Participants
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose Complete Pain/Symptom-Baseline	132 Participants	134 Participants
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose Complete Pain/Symptom-2 Hours Post-Dose	121 Participants	94 Participants
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose Complete Pain/Symptom-4 Hours Post-Dose	114 Participants	70 Participants
Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose Complete Pain/Symptom-8 Hours Post-Dose	106 Participants	58 Participants

SECONDARY outcome

Timeframe: 24 hours and 48 hours

Population: Subpopulation of the Intent-to-Treat population of subjects who were pain-free at 2 hours post-dose.

Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours.

Outcome measures

Measure	Placebo n=19 Participants	Sumatriptan/Naproxen Sodium n=59 Participants
Recurrence of Any Migraine Headache Pain Recurrence by 24 hours post-dose	5 Participants	13 Participants
Recurrence of Any Migraine Headache Pain Recurrence by 48 hours post-dose	6 Participants	13 Participants

Adverse Events

Placebo/Sumatriptan-Naproxen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sumatriptan-Naproxen/Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

Glaxo Smith Kline

Phone: 1-866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER